Pharmaceutical & Biotechnology – Focus on Regulationhttps://www.hlregulation.com
Thu, 23 May 2019 23:42:36 +0000en-UShourly1https://wordpress.org/?v=4.9.10FDA Chief of Staff: OTC reform remains “top priority” for FDAhttps://www.hlregulation.com/2019/05/23/fda-chief-of-staff-otc-reform-remains-top-priority-for-fda/
Thu, 23 May 2019 23:38:20 +0000https://www.hlregulation.com/?p=11209Speaking Tuesday, May 21, at the Consumer Health Products Association Regulatory, Scientific, and Quality Conference, FDA Chief of Staff Lauren Silvis emphasized that over-the-counter (OTC) monograph reform remains a “top priority” for FDA. Based on these comments, FDA is clearly not giving up on monograph reform: FDA has long engaged in this effort, and we will

]]>Speaking Tuesday, May 21, at the Consumer Health Products Association Regulatory, Scientific, and Quality Conference, FDA Chief of Staff Lauren Silvis emphasized that over-the-counter (OTC) monograph reform remains a “top priority” for FDA. Based on these comments, FDA is clearly not giving up on monograph reform:

FDA has long engaged in this effort, and we will continue to do so, working with all stakeholders and Congress to make clear that OTC monograph reform is a critical public health priority. It’s in the best interest of patients to modernize the monograph system. That means that FDA will continue to engage on this issue, until we have a system for OTC drugs that provides Americans what they need to better manage their own health care. We know it’s up to Congress to legislate on this issue, but you’ll continue to hear from FDA that OTC modernization will help consumers take charge of their own healthcare, promote safety and innovation, and help Americans lead healthier lives.

FDA’s perseverance on OTC monograph reform is particularly important because on May 16, the Senate passed FDA’s pandemic preparedness reauthorization legislation, S. 1379, after stripping out the monograph reform bill that had been paired with it in the House-passed H.R. 269. Now the Senate will need to take up the monograph reform bill separately, which could require a conference committee to iron out the differences or require the House to re-pass the monograph reform bill to match Senate action on the bill.

Silvis also stated that FDA is “pushing forward with” the advancement of the Nonprescription Safe Use Regulatory Expansion (NSURE) program that aims to help facilitate prescription (Rx) to nonprescription switches, as well as FDA’s issuance of a draft guidance titled “Innovative Approaches for Nonprescription Drug Products,” which (as we analyzed here) describes the agency’s thinking on switching Rx drugs to OTC in cases where the drug facts labeling alone is insufficient to ensure safety and efficacy in a nonprescription setting. Significantly, Silvis said that FDA is “actively working on a proposed rule that will provide more information on this topic.” We note that in the Spring 2019 Unified Agenda, FDA projected the proposed rule would be issued in December 2019. Note, however, that this is the fourth time since 2017 that FDA has pushed back the target date published in the Unified Agenda for issuing the proposed rule.

We will continue to monitor the agency’s advancement of OTC monograph reform and keep you apprised of developments in the space.

]]>FDA guidance may ease path to biosimilar interchangeabilityhttps://www.hlregulation.com/2019/05/15/fda-guidance-may-ease-path-biosimilar-interchangeability/
Wed, 15 May 2019 22:40:32 +0000https://www.hlregulation.com/?p=11183On Friday, FDA published the final guidance, “Considerations in Demonstrating Interchangeability With a Reference Product,” which is intended to assist sponsors in demonstrating that a biosimilar product is interchangeable with a reference product. Even as some of the details remain to be hashed out, the guidance makes clear FDA’s desire to minimize the burdens of

]]>On Friday, FDA published the final guidance, “Considerations in Demonstrating Interchangeability With a Reference Product,” which is intended to assist sponsors in demonstrating that a biosimilar product is interchangeable with a reference product. Even as some of the details remain to be hashed out, the guidance makes clear FDA’s desire to minimize the burdens of obtaining a determination of interchangeability. The guidance summarizes the important scientific considerations for demonstrating interchangeability, including:

The data and information recommended to support a demonstration of interchangeability

Considerations for the design and analysis of a switching study or studies to support a demonstration of interchangeability

Considerations regarding the comparator product in a switching study or studies

The finalized version of the guidance maintains the principles and structure of the January 2017 draft version, which we discussed here. In general, it provides a flexible framework that emphasizes the “totality of the evidence” in a given case, with interchangeability determinations guided by product-specific assessment of immunogenicity risks and other factors.

Switching studies

The final guidance makes clear that, for products that will be used more than once in a given patient, FDA generally will expect sponsors to conduct “switching studies,” i.e., clinical trials that switch patients back and forth between the reference biologic and the biosimilar. If the switching study is intended to support a finding of interchangeability for an already-licensed biosimilar, FDA says, existing postmarketing data for the biosimilar might be harnessed to support the interchangeability finding. If a interchangeability finding is requested with an initial biosimilar application, the agency contemplates that the switching study could be “integrated” with the study required to show biosimilarity. The final guidance also confirms that the primary endpoints for switching studies can be pharmacokinetic (PK) and/or pharmacodynamics (PD) markets, not clinical efficacy. Additionally, FDA generally will permit extrapolation of data from one condition of use to another.

The final guidance contains two notable changes from the draft: it permits switching studies to use non-U.S. versions of the reference product, and suggests flexibility regarding healthy subjects being used in switching studies. Additionally, the final guidance is much more general about the requirement to demonstrate interchangeability regarding the biosimilar and reference products’ presentation. In cutting much of the detail in the draft guidance, FDA has said it will issue a separate guidance to “provide more detailed recommendations on the data and information recommended to support the proposed interchangeable product’s presentation, container closure systems, and delivery device constituent parts and related issues.”

Encouraging interchangeable biosimilars

In a statement announcing the guidance, Acting FDA Commissioner Ned Sharpless emphasized FDA’s commitment to advancing the regulatory approval pathway for biosimilar and interchangeable products, citing agency plans to provide greater clarity for applicants and other stakeholders that are outlined in its Biosimilars Action Plan, which we discussed here. By way of example, Dr. Sharpless noted that there are no approved generic insulin products that can be substituted for branded products, but suggested that could change after March 2020, when insulin products approved under NDAs will be deemed to be licensed via BLAs, which may lead to biosimilar and interchangeable biosimilar insulin products. This guidance will help that happen, Dr. Sharpless said.

If you have any questions about the final guidance or may be interested in applying for an interchangeability designation, please contact any of the authors of this blog or the Hogan Lovells lawyer with whom you regularly work.

]]>FDA Doubles Down on MUsT Studies for Sunscreens and Issues Final Guidance on Absorption Studies that Will Likely Be Needed for Continued Marketinghttps://www.hlregulation.com/2019/05/14/fda-doubles-down-must-studies-for-sunscreens-issues-final-guidance-absorption-studies/
Tue, 14 May 2019 19:58:12 +0000https://www.hlregulation.com/?p=11171On May 10, 2019, FDA published a notice of availability for a final guidance document on Maximal Usage Trials (MUsT studies) for topically applied active ingredients being considered for OTC drug monographs, including sunscreens. As FDA has previously explained, the guidance states that MUsT studies can identify the potential for the systemic exposure for a

]]>On May 10, 2019, FDA published a notice of availability for a final guidance document on Maximal Usage Trials (MUsT studies) for topically applied active ingredients being considered for OTC drug monographs, including sunscreens. As FDA has previously explained, the guidance states that MUsT studies can identify the potential for the systemic exposure for a topically-applied active ingredient. FDA believes that this information is necessary to determine whether additional safety studies are needed to support a finding that the ingredient is generally recognized as safe and effective (GRASE) for its intended use.

FDA’s reliance on MUsT studies has been a subject of controversy with the sunscreens industry. Industry has argued that MUsT studies are unreasonably expensive and sunscreen products have been marketed in the U.S. and around the world for decades without adverse events or data identifying safety concerns related to absorption. To support an OTC drug monograph, FDA has said that a MUsT study should evaluate the ingredient in a range of formulations, which further adds to the cost and time needed for such a study.

FDA: Absorption Is Not Just a Theoretical Concern

However, just a few days before the issuance of the MUsT guidance, on May 6, 2019, FDA released a statement reaffirming the agency’s reliance on MUsT studies for evaluating sunscreens. The FDA statement highlights an FDA-funded study published on the same day in the Journal of the American Medical Association (JAMA), evaluating the absorption of four sunscreen ingredients: avobenzone, oxybenzone, octocrylene, and ecamsule. The FDA statement was intended to emphasize that “that absorption of sunscreens is not just a theoretical concern.” According to the JAMA article, all four ingredients were absorbed such that systemic concentrations greater than 0.5 ng/mL (nanograms per milliliter) were reached after four applications on day 1. FDA’s statement reflects the agency’s position that sunscreen active ingredients absorbed above this threshold “would generally need to undergo further testing to help determine if they increase the risk for cancer, birth defects or other adverse effects.”

Private Meetings in Support of Developing MusT Studies

Highlights of the MUsT guidance include the following:

FDA encourages MUsT study sponsors to seek FDA’s advice before initiating a MUsT study to support OTC monograph status for a particular ingredient.

Although the results of MUsT study would ultimately need to be included in the public docket to support inclusion of a particular active ingredient in the OTC drug monograph, FDA is willing to hold private meetings with sponsors to discuss MUsT protocol details that are not yet part of the public record. This would give sponsors the opportunity to privately discuss and receive input from FDA about their preliminary plans to generate MUsT data.

However, minutes from the private meetings, including a summary of general concepts discussed, would subsequently be submitted to the public docket. But information that sponsors would not routinely publicly disclose, such as chemistry data and detailed protocols, would not be disclosed to the extent that they constitute confidential commercial or trade secret information.

Rulemaking Deferral Requests

The issuance of the guidance follows FDA’s decision published on April 18, 2019, to extend both the comment period on the proposed sunscreens rule and the period to request a rulemaking deferral for certain active ingredients. FDA granted a 30-day extension, until June 27, 2019. The extension is of particular importance for the manufacturers of the 12 sunscreen ingredients that were identified in the proposed rule as requiring additional data and information, in particular relating to absorption, to determine whether the ingredients could be established as GRASE. To provide the absorption data, the proposed rule stated that FDA expects that data from a MUsT study “will be needed to support an adequate assessment of safety for most sunscreen active ingredients.” 84 FR 6204, 6213 (Feb. 26, 2019).

FDA invited requests for the agency to defer rulemaking for certain ingredients, to allow for the submission of the necessary data. But the language of the proposed rule appeared to signal that FDA would not grant such deferrals unless it appeared that the “sum of the data … would be adequate” to provide all the data necessary to establish GRASE. 84 FR 6204 at 6249.

We believe that FDA is not likely to grant a deferral request for a sunscreen ingredient without a commitment to conduct a MUsT study. And additional safety studies are likely to be expected for at least the four ingredients identified in the JAMA article as exceeding FDA’s absorption threshold. However, FDA’s May 6 statement described above adopted a softer tone for sunscreen manufacturers willing to commit to MUsT studies, stating that “we understand that manufacturers may need additional time to generate new data and information” and will consider deferral requests for this purpose.

In a previous post, we explained that FDA is facing a statutory deadline to finalize the sunscreens monograph by November 26, 2019. Now that FDA has granted an extension for comments, it will be even more difficult for FDA to meet with this deadline. It is possible that FDA will miss the deadline and take its chances on being sued. But it is also possible that FDA will grant deferrals for any of the 12 ingredients for which there is a credible commitment to conduct the necessary MUsT and related studies. The studies could be conducted over an extended period of time, which would allow for continued marketing during the interim period, as long as FDA continues to renew the deferrals. Taking a generous approach to deferrals could ease the path for FDA to finalize the remainder of the rule in accordance with the statutory deadline.

If you have any questions about the MUsT guidance or may be interested in submitting a comment to the proposed rule or deferral request, please contact any of the authors of this blog or the Hogan Lovells lawyer with whom you regularly work.

]]>FDA publishes final guidance on ANDA/505(b)(2) NDA pathwayshttps://www.hlregulation.com/2019/05/10/fda-publishes-final-guidance-anda-505b2-nda-pathways/
Fri, 10 May 2019 21:40:51 +0000https://www.hlregulation.com/?p=11162On Thursday, FDA published the final guidance document, “Determining Whether to Submit an ANDA or a 505(b)(2) Application” that contains minor revisions to the October 2017 draft guidance. The final guidance contains no significant substantive changes to the draft version, but here are a few interesting tidbits: FDA will respond to comments seeking clarification on

]]>On Thursday, FDA published the final guidance document, “Determining Whether to Submit an ANDA or a 505(b)(2) Application” that contains minor revisions to the October 2017 draft guidance. The final guidance contains no significant substantive changes to the draft version, but here are a few interesting tidbits:

FDA will respond to comments seeking clarification on the process for obtaining therapeutic equivalence evaluations in a forthcoming guidance document.

FDA clarified that petitioned ANDAs are expected to have the same therapeutic effect as the reference listed drug.

Revisions to the discussion about what kind of information may be submitted in an ANDA seem to emphasize FDA’s “significant flexibility” on this issue.

As always, the devil is in the details. Much policy will be developed in the context of individual applications. For more information on how to strategically approach drug approval pathways (yours or a competitor’s), please contact any of the authors of this alert or the Hogan Lovells lawyer with whom you regularly work.

]]>On April 23, FDA issued draft guidance entitled “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C,” which aims to clarify how firms in a product distribution chain should prepare to facilitate timely initiation of a voluntary recall, respond to an indication of a problem with a distributed product, and initiate a voluntary recall. Overall, FDA emphasizes the importance of pharmaceutical, biotechnology, medical device, food, tobacco, and animal products firms having made plans in advance of a recall so that they are prepared, should one become necessary.

How to be “Recall Ready”

In order to facilitate timely initiation of a voluntary recall, the draft guidance recommends firms make the following preparations:

Designate specific employees with recall-related responsibilities who possess the authority to take the steps needed to implement a product recall when necessary.

Train personnel on recall-related responsibilities, and consider additional preparatory steps such as mock recalls and establishing metrics appropriate to a recall plan.

Create a recall communications plan that identifies specific points-of-contact, and that contains draft templates that help the firm issue recall communications promptly.

Identify possible recall-associated reporting requirements, for circumstances when a significant problem with a distributed product may trigger a requirement to make a separate report to FDA, g., a report to the Reportable Food Registry or reports under 21 CFR 806 for medical devices.

Ensure adequate product coding to make possible positive lot identification and to facilitate the effective recall of all violative lots.

Maintain product distribution records for a period of time that exceeds the shelf life and expected use of the product and is at least the length of time specified in other applicable regulations concerning records retention. The records should contain enough detail to identify the consignees that actually received the recalled product and must conform to any applicable requirements.

The draft guidance further advises a firm to maintain written recall initiation procedures that assign responsibility and describe the steps to perform all actions related to initiating a recall, as appropriate to the specific products and business model of the firm or facility. These procedures should include actions such as (1) ceasing distribution, shipment or sales of affected product; (2) developing a recall strategy; (3) notifying direct consignees; and (4) when appropriate, notifying the public of the recall.

Steps for responding to an indication of a problem

The draft guidance outlines specific steps a firm should take if there is an indication of a problem with a distributed product:

Identify the problem using indicators such as an internal report of a product specification deviation or out-of-specification testing results for a product.

Promptly investigate the problem to ensure that potential risks are consistently assessed and investigated for products potentially affected.

Make decisions about whether a recall is necessary, and if so, about the scope and depth of that recall.

This draft guidance is part of a series of policy steps FDA is taking to strengthen and modernize the process for issuing a public warning about a voluntary recall and for notification of recalls, as we recently discussed in a February 26 alert. FDA Associate Commissioner for Regulatory Affairs Melinda K. Plaisier said in a press release that “there is more that needs to be done,” adding that FDA “will continue its efforts to improve recalls, and will encourage the use of new technologies and other tools that can assist in those efforts.”

The voluntary recall draft guidance is open for public comment until June 24; please contact any of the above-listed authors if you have any questions about the guidance or may be interested in commenting. We will continue to keep you apprised of new FDA efforts to inform companies on proper procedures for voluntary recalls.

]]>Poland: Impact of a no-deal Brexit scenario on biocidal products’ data changes, and the validity of parallel import licences for medicinal productshttps://www.hlregulation.com/2019/04/01/poland-impact-of-a-no-deal-brexit-scenario-on-biocidal-products-data-changes-and-the-validity-of-parallel-import-licences-for-medicinal-products/
Mon, 01 Apr 2019 11:49:34 +0000https://www.hlregulation.com/?p=11103The President of the Polish Office for the Registration of Medicinal Products, Medical Devices, and Biocidal Products issued two more Brexit related communiques.[1] The first Brexit related communique concerned changes to: data which was included within marketing permissions, data being made available on the market, and data concerning the use of biocidal products. The second

]]>The President of the Polish Office for the Registration of Medicinal Products, Medical Devices, and Biocidal Products issued two more Brexit related communiques.[1]

The first Brexit related communique concerned changes to: data which was included within marketing permissions, data being made available on the market, and data concerning the use of biocidal products. The second concerned the impact of Brexit on the validity of parallel import licences.

Data included within marketing permissions, data made available on the market, and data concerning the use of biocidal products

In the event of a no-deal Brexit, the President of the Office has recommended the immediate introduction of the following changes to the relevant documentation:

– the change of a biocidal product’s marketing authorisation holder to entities established or represented in the EU (EEA countries, or Switzerland),

– the change of the authorisation holder for making data available on the market, and data concerning the use of biocidal products, to holders established or represented in the EU (EEA countries, or Switzerland).

At the same time, the Office has asked companies to keep up to date with the information published on the websites of the European Chemicals Agency (ECHA)[2].

Moreover, suppliers of the active substances or biocidal products included in the list referred to in Article 95 of Regulation (EU) No 528/2012 concerning biocidal products must be established or represented in the EU (EEA, or Switzerland).

Validity of parallel import licences for medicinal products

In case of a no-deal Brexit, medicinal products with parallel import licenses, in which the UK is indicated as the exporting country, will no longer be considered as having been imported from a member state of the EU, or a member state of the European Free Trade Agreement (EFTA), but instead from a third country.

Therefore, these medicinal products will be imported into Poland contrary to the definition of a parallel import as defined in the Polish pharmaceutical law. As a result, any parallel import licences in which the UK is designated as an exporting country will be revoked after the Brexit date.

]]>On February 26, FDA published the proposed rule, “Sunscreen Drug Products for Over-the-Counter Human Use,” which describes the conditions under which Over-the-Counter (OTC) sunscreen monograph products are generally recognized as safe and effective (GRASE) and not misbranded. Primarily, the proposed rule seeks additional information on sunscreen ingredients so that FDA can evaluate their GRASE status in light of changed conditions, including substantially increased sunscreen usage and exposure, and evolving information about the potential risks associated with these products. The proposal is for a final monograph on sunscreens, which would substantially amend the 1999 final rule on sunscreens that was stayed before its effective date.

Challenging Timeframe for FDA

Under the Sunscreen Innovation Act (SIA), 21 USC 360-fff-5, FDA is required by law to finalize and make effective the sunscreens final monograph by November 26, 2019. FDA is aware that time is running out on this deadline, and the agency is vulnerable to litigation if FDA fails to meet the statutory deadline. See Ctr. for Food Safety v. Hamburg, 954 F. Supp.2d 965 (N.D. Cal. 2013) (providing declaratory relief regarding statutory deadlines for rulemaking).

Having the rule become effective by November 26, 2019, will be very challenging for FDA. Under the Administrative Procedure Act, 5 USC 553(d), a rule generally cannot become effective until at least 30 days after publication, which means that FDA should publish the final rule by October 25. But the comment period on the proposed rule does not close until May 28, which gives FDA less than five months to prepare and publish the final rule. This timeframe will be very difficult for FDA for several reasons. First, this is a lengthy and complex rule that has been under development for many years. The proposed rule covers 71 (three-column) pages in the Federal Register, including multiple scientific, legal, and policy issues. FDA will need to address multiple comments and deferral requests. Second, OTC drug monograph work requires specialized knowledge, and FDA has a relatively small team dedicated to this work. Third, ordinarily, a final rule would be expected to be submitted to OMB for interagency review at least 90 days before publication, unless OMB waives review. See Executive Order 12866, Sec. 6(b)(2)(B). Adding time for the review processes at FDA and, possibly, the Department of Health and Human Services (HHS), further adds to the challenge facing the OTC drug team at FDA.

Sunscreen Ingredients and Enforcement Policy

The proposed rule states that there is still not enough evidence to determine the GRASE status of most of the ingredients from the stayed 1999 final sunscreens rule. The proposal does not address the sunscreen active ingredients that were originally submitted under FDA’s Time and Extent Application regulations, which are being addressed through the process established under the SIA. However, FDA proposes that two sunscreen ingredients are GRASE (Category I) and two are not GRASE (Category II). The ingredients proposed for Category I are zinc oxide and titanium dioxide. The ingredients proposed for Category II, based on safety concerns, are para-aminobenzoic acid (PABA) and trolamine salicylate. FDA states that neither of these ingredients is currently marketed in a sunscreen product in the U.S.

For the remaining twelve ingredients from the stayed 1999 sunscreens rule, FDA is seeking more information (Category III), based in part on concerns about the lack of data characterizing their absorption or, in the case of oxybenzone, concerns about the effect of absorption. The twelve ingredients are: cinoxate, dioxybenzone, esulizone, homosalate, meradimate, octinoxate, octisalate, octocrylene, padimate O, sulisobenzone, oxybenzone, and avobenzone. Many of these ingredients are in sunscreens that are currently marketed in the U.S. The data gaps that FDA has identified for these products are significant and are not likely to be resolved before FDA finalizes this rule as required by the statutory deadline. When FDA publishes the final sunscreen rule the agency will have two choices for each of these Category III ingredients: FDA can either (1) determine that the ingredients are not GRASE, which will require an NDA for continued marketing, or (2) defer rulemaking for these ingredients to allow the necessary research to be conducted, submitted, and evaluated.

The proposed rule states that any requests for the deferral of rulemaking must be submitted within the 90-day comment period (by May 28, 2019). Data submitted in such “timely and complete” deferral requests will be reviewed along with data and information already in the docket. “FDA will determine whether the sum of the data, if timely submitted, is likely to be adequate to provide all the data that are necessary to make a determination of general recognition of safety and effectiveness.” 84 FR 6204, 6249 (Feb. 26, 2019). This language in the proposed rule implies that even if a deferral request is submitted within the deadline, FDA may decide not to grant a deferral for certain ingredients for which FDA believes the data are unlikely to be adequate. Products containing these ingredients would need to be reformulated or come off the market.

However, FDA would extend the compliance period for one year after the effective date of the final rule, allowing products to be sold that are already delivered for introduction into interstate commerce before May 28, 2020. This would be a substantial shift from the enforcement policy that has been in place for sunscreen ingredients for more than 20 years and was revised less than a year ago for all of the ingredients in the stayed 1999 sunscreens rule. However, the May 2018 enforcement policy was clear that it “only applies until a final sunscreen monograph becomes effective.” Nonetheless, after many years of little change in the active ingredients in sunscreen products marketed in the U.S., significant change is clearly on the horizon.

What to Make of All of This?

Clearly FDA has the authority to seek additional safety data to assess the GRASE status of these sunscreen ingredients. However, companies may argue in their comments on the proposed rule that these products have a long history of use in the U.S. by millions of consumers without any significant harm, and thus have a favorable risk benefit profile. Further, they will likely assert that when weighing the dangers of skin cancers associated with sun exposure versus the absorption concerns FDA has, that the products should be considered GRASE.

Next, the twelve Category III sunscreen ingredients are used in numerous sunscreen products in the U.S. Ninety days is not a long time for companies to decide, perhaps by banding together, to evaluate available data on absorption for each of the ingredients and to seek deferrals. If deferrals are not sought and/or if FDA determines that the data are unlikely to be adequate and denies deferral requests, some or all of these ingredients may be determined to be not GRASE (Category II) in the final rule. If FDA decides not to grant deferrals for all twelve of these ingredients, the U.S. market would be cleared of chemical sunscreens, and only result in two mineral-based options. An unintended effect of this scenario may be that less consumers use sun protection products, thereby increasing unprotected sun exposure—definitely not a desirable public health outcome.

It is worth noting that the U.S. has been criticized for years as lagging behind the rest of the world in our sunscreen technology. Numerous other countries allow ingredients not considered GRASE in the U.S. on their retail shelves. The SIA was enacted, in part, to catch us up by allowing additional sunscreen active ingredients in to the drug review. FDA has evaluated several time and extent applications for additional ingredients using the process set forth in the SIA, but has found them all to have significant data gaps. Now with the looming deadline to finalize the sunscreen monograph, and the potential to find fourteen additional ingredients as non-monograph, the U.S. sunscreen market may significantly depart from the variety of skin protection availability elsewhere around the globe, which could have potentially adverse net consequences for public health.

If you have any questions about the proposed rule or may be interested in submitting a comment or deferral request, please contact any of the authors of this blog or the Hogan Lovells lawyer with whom you regularly work.

]]>Poland: New Medical Research Agencyhttps://www.hlregulation.com/2019/03/12/poland-new-medical-research-agency/
Tue, 12 Mar 2019 11:01:44 +0000https://www.hlregulation.com/?p=11086On Monday, March 4, the President signed a bill on the establishment of a new institution, the Medical Research Agency (ABM). The new Agency will be a specialized body of experts who will work on innovation in Polish medicine, focusing on areas related to oncology, haematology and rare diseases. The activities of the Agency will

]]>On Monday, March 4, the President signed a bill on the establishment of a new institution, the Medical Research Agency (ABM).

The new Agency will be a specialized body of experts who will work on innovation in Polish medicine, focusing on areas related to oncology, haematology and rare diseases. The activities of the Agency will primarily consist in co-financing scientific research and development work as well as interdisciplinary projects, with particular emphasis on clinical, observational and epidemiological research. Moreover, the Agency will be able to initiate and carry out its own scientific research and development work and, additionally, to expand international cooperation.

According to the Ministry of Health, the Agency’s main area of interest will be non-commercial clinical trials of medicinal products and medical devices of all phases that constitute currently only around 1% of the total number of clinical trials. Non-commercial studies have not so far been financed by the pharmaceutical companies. However, they are considered equally important as they prove or verify the effectiveness of medicinal products and medical technologies.

The Agency will be managed by the President of the ABM appointed in for a term of 6 years by the Minister of Health and by the Agency’s Scientific Council.

The Agency’s budget in 2019 will amount to approximately PLN 50 million, and in 2028 it is expected to be around PLN 1 billion. The body will be financed by the state budget and a write-off from the National Health Fund (NFZ) in the amount of 0.3% of its revenues. However, the money from the NFZ write-off will be used only for non-commercial clinical studies. The Agency may also be financed from other sources, such as donations, the EU budget, international research programmes or ABM’s business activity in the area of publishing or commercialisation of scientific research results.

The establishment of the Agency is expected to provide institutional support for the financing of analyses and scientific research in health care and contribute to the growth of innovation in Polish medicine. According to the Ministry of Health, the first research competitions are to be announced in the second half of this year.

]]>Poland: official position of the competent authority on consequences for medical devices in the event of a no-deal brexithttps://www.hlregulation.com/2019/03/05/poland-official-position-of-the-competent-authority-on-consequences-for-medical-devices-in-the-event-of-a-no-deal-brexit/
Tue, 05 Mar 2019 15:56:52 +0000https://www.hlregulation.com/?p=11063On 1 March 2019[1], the President of the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products issued yet another communique concerning consequences of Brexit, this time with respect to the medical devices. It is announced that in the event of a “no-deal” Brexit, as from 30 March 2019, the United Kingdom

]]>On 1 March 2019[1], the President of the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products issued yet another communique concerning consequences of Brexit, this time with respect to the medical devices.

It is announced that in the event of a “no-deal” Brexit, as from 30 March 2019, the United Kingdom will be considered a third country. In this case the following consequences will affect:

notified bodies and conformity certificates from the UK

Notified bodies (BSI Assurance UK Ltd, Lloyd’s Register Quality Assurance Ltd, SGS United Kingdom Ltd, and UL International UK Ltd) will lose their notification. As a consequence, the certificates of conformity issued by these bodies will no longer be valid.

The exception is when another notified body assumes direct responsibility for the devices and undertakes to re-certify these products within 12 months. The certificates will then remain valid for this period. The validity of the certificate can only be stated with the written confirmation from the new notified body. However, the Office emphasizes that this is a national regulation and these certificates might not be recognized in other EU member states.

manufacturers from the UK

Any manufacturer residing or established in the United Kingdom will be required to appoint an authorised representative. The name and address of this representative must be stated on the label or in the instructions for use. If the manufacturer is from a third country and its former authorised representative resides, or has its registered seat, in the UK, it must appoint a new representative with its seat or residence in the Member State.

Moreover, neither manufacturers nor authorised representatives, either resident or established in the UK, will now be allowed to sponsor clinical trials of medical devices.

distributors from the UK

In the cases referred to above, the distributors will be obliged to notify the President of the Office of any changes concerning the authorised representative of a medical device which manufacturer or authorised representative is either resident or established in the UK.

In addition, distributors importing medical devices from the UK will now become importers. They will not be required to re-notify the President of the Office about imported devices if they have already done this before 30 March. However, they will still be obliged to notify the President of the Office of any aforementioned change concerning the manufacturer or representative.

The consequences of Brexit described above will not apply to medical devices which, before 30 March 2019, were legally marketed in a Member State other than the UK. These devices can continue to be marketed and put into service in Poland.

]]>Poland: Post-registration changes required in case of no-deal Brexithttps://www.hlregulation.com/2019/02/25/post-registration-changes-in-case-of-no-deal-brexit/
Mon, 25 Feb 2019 14:06:24 +0000https://www.hlregulation.com/?p=11052On 25 February 2019[1], the President of the Polish Office for the Registration of Medicinal Products, Medical Devices, and Biocidal Products issued a communique concerning the necessary post-registration changes in the event of a “no-deal” Brexit. In the event of a “no-deal” Brexit, the President of the Office has recommended that companies immediately introduce post-registration

]]>On 25 February 2019[1], the President of the Polish Office for the Registration of Medicinal Products, Medical Devices, and Biocidal Products issued a communique concerning the necessary post-registration changes in the event of a “no-deal” Brexit.

In the event of a “no-deal” Brexit, the President of the Office has recommended that companies immediately introduce post-registration changes in their medicinal product documentation. These changes concern:

the marketing authorisation holder,

the place of manufacture / place of import, where batch controls are carried out,

the Manufacturer / Importer which releases the batch,

the Qualified Person responsible for Pharmacovigilance,

the Summary of the Pharmacovigilance System Master File.

The Office has emphasised that the above post-registration changes should be implemented before 30 March 2019 in order to maintain compliance with EU legislation.

At the same time, the Office has asked companies to keep up to date with the information published on the European Medicines Agency (EMA), and of Co-ordination Group for Mutual Recognition and Decentralised procedures – Human (CMDh) websites.

The new communique constitutes another confirmation (after the Polish Minister of Health’s statement on the effects of Brexit on reimbursement) that the Polish authorities do not plan to adopt any special procedures concerning the implications of Brexit on medicinal products. Therefore, in the case of products registered in Poland, they recommend that companies apply for the relevant post-registration changes as soon as possible, if they have not already done so.